Gonal-F (follitropin alfa) Injection

Gonal-F is a prescription medicine containing follicle-stimulating hormone (FSH).

It is used to:

• help healthy ovaries develop and release an egg to help you get pregnant
• cause your ovaries to make multiple eggs as part of an Assisted Reproductive Technology (ART) program
• help develop and produce mature sperm

Side effects of Gonal-F

Gonal-F may cause severe side effects in women and men, including:

• severe allergic reactions: shortness of breath, swelling of your face, itchy, red bumps or rash on your skin (hives)
• blood vessel problems (thrombophlebitis), stroke, loss of your arm or leg, blood clot in your lung (pulmonary embolus), heart attack

Gonal-F may cause ovarian hyperstimulation syndrome (OHSS) in women:

• OHSS is a serious and common side effect that can cause fluid buildup in your stomach, chest, and heart, and blood clots
• Symptoms include: trouble breathing, severe lower stomach pain, weight gain, nausea, vomiting, diarrhea, decreased urine output, stomach or pelvic pain, shoulder pain, neck pain, rectal pain, nausea and vomiting
• Risk factors for OHSS include: age, certain sperm problems, genetic background, a pregnancy with more than 1 baby at a time

Common side effects of Gonal-F include: skin problems, breast enlargement, injection site pain, seborrhea, tiredness

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Gonal-F. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Dosage for Gonal-F

Important Dosage And Administration Information

• Only physicians experienced in infertility treatment should treat women with Gonal-F.
• Use the lowest effective dose of Gonal-F to prevent complications and multiple births.
• Select candidates for Gonal-F therapy based on proper evaluation and diagnosis.
• Follow proper preparation and administration instructions for Gonal-F.

Preparation Of Gonal-F And Selection Of Injection Site

27-gauge injection syringe – Illustration

• Store lyophilized Multi-Dose vials refrigerated or at room temperature and protected from light.
• Visually inspect the medication for particulate matter and discoloration before administration.
• Use the accompanying syringes with unit dose markings for accurate dosage.
• Each Gonal-F Multi-Dose Vial delivers either 450 or 1050 International Units of follitropin alfa.

Dosing For Ovulation Induction

Prior to initiation of treatment:

• Perform a complete evaluation of the woman’s fertility status
• Administer a starting dose of 75 International Units of Gonal-F daily for 14 days
• Adjust the dose based on ovarian response and continue treatment until adequate response is achieved

Dosing For Multiple Follicle Development As Part Of An Assisted Reproductive Technology (ART) Cycle

Prior to initiation of treatment:

• Perform a complete evaluation of the woman’s fertility status and diagnose the cause of infertility
• Administer a starting dose of 150 International Units of Gonal-F daily until sufficient follicular development is achieved
• Adjust the dose based on ovarian response, but do not exceed 450 International Units per day
• Administer hCG to induce final follicular maturation
• Withhold hCG if increased risk of OHSS is detected

Dosing For Induction Of Spermatogenesis In Males With Azoospermia And Primary Or Secondary Hypogonadotropic Hypogonadism

Prior to initiation of treatment:

• Confirm azoospermia and perform a thorough medical and endocrinologic evaluation
• Normalize serum testosterone levels with hCG alone before starting Gonal-F
• Administer Gonal-F and hCG subcutaneously three times a week
• Adjust the dose based on response, but do not exceed 300 International Units three times per week
• Administer Gonal-F for up to 18 months to achieve adequate spermatogenesis

Missed Dose

Do not double the next dose if a woman or a man misses or forgets to take a dose of Gonal-F.